MDR Certification for our Hip and Knee Surgery Product Ranges

The Medical Device Regulation (MDR) (EU) 2017/745 establishes the legal framework governing the placing on the market, making available on the market, and putting into service of medical devices within the European Union.

Progressively applied since May 2021, the MDR replaces Directive 93/42/EEC.

Its objective is to harmonise regulatory requirements across European countries while strengthening patient safety throughout the entire lifecycle of medical devices.

The Regulation introduces enhanced requirements relating to:

• Medical device design
• Risk management
• Clinical performance evidence
• Product traceability
• Post-market surveillance (PMS)

Its purpose is to ensure that medical devices placed on the European market are subject to a high level of safety, quality and traceability.

To meet these new regulatory requirements, an extensive compliance programme was implemented across all of our medical device product ranges.

This project included the updating of technical documentation and the strengthening of our Quality Management System, in collaboration with our Notified Body, KIWA Cermet.

The project involved the long-term commitment of several internal departments, including:

• Quality
• Regulatory Affairs
• Clinical Affairs
• Research & Development
• Manufacturing

This initiative reflects our commitment to continuous improvement and ongoing compliance with European regulatory requirements.

Following several years of assessment, our hip and knee surgery implants obtained MDR certification on 9 February 2026.

This certification confirms that the devices comply with the requirements of Regulation (EU) 2017/745 and allows them to remain on the European market under the current regulatory framework.

Discover our dedicated hip surgery product range, along with our article highlighting more than ten years of development and experience in this field.

Discover our dedicated knee surgery product range, along with our article presenting more than ten years of expertise in ligament reconstruction.

This certification represents an important milestone in the ongoing work carried out by our teams to ensure the compliance, quality and lifecycle monitoring of our medical devices.

Obtaining MDR certification also reflects the maturity of our internal processes and our teams’ ability to manage complex regulatory projects over an extended period.

It is supported by:

• Updated technical documentation
• A Quality Management System strengthened to meet regulatory requirements
• Continuous monitoring of European regulatory requirements
• Ongoing collaboration between the company’s different departments

As part of this milestone, new “40 Years” packaging has been introduced for selected product references to celebrate the company’s anniversary.

This initiative reflects our long-term commitment to continuously adapting and developing our product ranges in line with regulatory requirements and evolving industry practices.

The MDR represents a major evolution in the European regulatory framework for medical devices.

The work carried out over the past several years strengthens the compliance of our product ranges and supports their long-term development while meeting the requirements of the healthcare sector.

Learn more

To learn more about our quality and regulatory commitments, please consult our Quality Policy :